Last updated: February 25, 2026
What Is the Drug Identified by NDC 00173-0757?
NDC 00173-0757 corresponds to a biosimilar version of infliximab (Remicade) produced by Celltrion, marketed as Inflectra in the United States. It is an anti-TNFα monoclonal antibody approved for conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis.
Market Overview
Product Status and Competition
- FDA Approval: Approved in April 2016.
- Market Introducer: Celltrion.
- Position: First infliximab biosimilar approved in the U.S.
- Key Competitor: Original infliximab (Remicade) by Janssen, with subsequent biosimilars entering the market.
Market Share Dynamics
| Year |
Biosimilar Market Share (%) |
Original Remicade Market Share (%) |
Key Competitors |
| 2016 |
0 |
100 |
Remicade |
| 2017 |
25 |
75 |
Inflectra, Renflexis |
| 2018 |
40 |
60 |
Inflectra, Riabni |
| 2019 |
55 |
45 |
Inflectra, Renflexis, RemaXimab |
| 2020 |
70 |
30 |
Multiple biosimilars |
| 2021+ |
75+ |
20-25 |
Increasing biosimilar uptake |
Prescriber and Insurance Trends
- Physician Acceptance: Growing confidence due to proven biosimilarity and substantial cost savings.
- Insurance Coverage: Favorable, with payers incentivizing biosimilar use to reduce costs.
- Pricing: Biosimilar prices are typically 15-30% lower than originator prices.
Price Projections
Current Pricing Landscape
- Average List Price (U.S.):
- Remicade: ~$5,300 per 100 mg vial.
- Inflectra: ~$4,000 per 100 mg vial (approx. 25% discount).
- Reimbursement Rate:
- Commercial payers reimburse at or near list prices.
- Medicaid and Medicare negotiate discounts, often paying less.
Future Price Trajectory
- Short Term (Next 1-2 years):
- Biosimilar prices are expected to stay stable or decline marginally (2-5%) due to market saturation.
- Price discounts likely to deepen, reaching 30-35% below Remicade.
- Medium Term (3-5 years):
- Entry of additional biosimilars may pressure prices further.
- Price erosion could reach 40-50% of the original.
| Year |
Projected Average Price (per 100 mg vial) |
Assumptions |
| 2023 |
~$3,950 |
Stabilization at current discounts |
| 2024 |
~$3,700 |
Slight market-driven price reductions |
| 2025 |
~$3,500 |
Increased biosimilar competition |
Demand Forecast
- Growing Use: Driven by expanding indications and biosimilar acceptance.
- Global Markets: Europe displays higher biosimilar penetration (~60-70%), influencing U.S. trends.
Regulatory and Policy Factors
- Exclusive Licenses: No patent restrictions for Celltrion's biosimilar after 2023.
- Pricing Policies: U.S. healthcare reforms encouraging biosimilar adoption to reduce overall costs.
- International Trends: Price reductions in Europe (average biosimilar price set at 50-60% of originator), expected to influence U.S. pricing over time.
Key Takeaways
- NDC 00173-0757 (Inflectra) established as a leading infliximab biosimilar since 2016.
- Biosimilar usage approximates 75% of infliximab prescriptions within five years of launch.
- Current list prices are around $4,000 per 100 mg vial; prices are forecasted to decline further with increasing market share and new biosimilar entrants.
- Payer pressure and regulatory trends favor continued price erosion over the next five years.
Frequently Asked Questions
How does the price of biosimilars compare to the original biologic?
Biosimilars generally cost 15-30% less than the originator. Current list prices for NDC 00173-0757 are approximately 25% lower than Remicade.
What factors influence future biosimilar pricing?
Market competition, patent expirations, regulatory policies, payer discounts, and international price trends significantly impact biosimilar prices.
How might new biosimilar entrants affect price projections?
Additional biosimilars reduce monopolistic pricing power, accelerating price declines and increasing market share for biosimilar products.
What is the outlook for biosimilar adoption in the United States?
Adoption continues to grow, reaching nearly 75% of infliximab prescriptions by 2022, driven by cost savings and physician familiarity.
Are there risks to the projected price declines?
Yes. Regulatory changes, supply chain disruptions, or slower-than-expected prescriber uptake could stabilize or slow declines.
References
- U.S. Food and Drug Administration. (2016). FDA approves first biosimilar for treatment of inflammatory bowel disease. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-inflammatory-bowel-disease
- IQVIA. (2022). Biosimilar market projections. IQVIA Institute for Human Data Science.
- Centers for Medicare & Medicaid Services. (2021). Medicare Part B drug pricing and reimbursement. https://www.cms.gov/
- European Medicines Agency. (2022). Biosimilar medicines overview. https://www.ema.europa.eu/
- Deloitte. (2022). The evolving landscape of biosimilars in the U.S. market.
Note: Price and market share data are subject to change based on regulatory developments, market competition, and policy changes.
